View clinical trials related to Brain Injuries.
Filter by:Background 25,000 infants are born extremely preterm every year in Europe. This group of infants carries a high risk of death and subsequent cerebral impairment for the infant, especially in the first 72 hours of life. Mortality is about 20%, and about 25% of survivors live with either cerebral palsy or low intelligence quotient. Preventative measures are keys to reducing mortality and morbidity in this population. There is evidence that the cerebral oxygenation time spent out of range (time with hypoxia or hyperoxia) is associated with poor outcome in infants. Near-infrared spectroscopy (NIRS) has been used to monitor tissue oxygenation since the mid-1980s, and quantification of oxygenation (rStO2) in a percentage from 0 to 100% has been possible for 10 years. From almost 400 preterm infants normal ranges of rStO2 has been determined to be from 55% to 85%. Still, there are no clinical trials and thus no solid evidence of the clinical utility of NIRS in preterm infants. Thus, research on the benefits and harms of cerebral monitoring using NIRS as a part of clinical management of premature infants is much needed. Objectives The primary objective of the SafeBoosC trial is to examine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants during the first 72 hours of life through the application of cerebral NIRS oximetry and implementation of an rStO2-specific clinical treatment guideline. We hypothesise that by using the specified treatment guideline to respond to cerebral monitoring readings outside the target range, we would reduce the burden of hypo- and hyperoxia and consequently reduce brain injury. Trial design This is an investigator-initiated randomised, blinded, multinational, phase II feasibility clinical trial involving preterm infants from 12 European countries. Inclusion criteria The inclusion criteria are: neonates born more than 12 weeks preterm (gestational age up to 27 weeks and 6 days); decision to conduct full life support; parental informed consent; and cerebral NIRS oximeter placed within 3 hours after birth. Sample size With a 50% reduction of the area outside the normal range of oxygenation in %hours in the experimental group compared to the control group as the minimal clinically significant difference, a standard deviation of the area outside the normal range of 83.2 %hours, a type I error (alpha) of 5%, and a type II error of 0.05 (power of 95%) inclusion of 75 preterm infants in the experimental group and 75 preterm infants in the control group is required. The inclusion of twins are likely to decrease power, so it has been decided to increase sample size to 165 on a pragmatic basis of estimating intracluster correlation, control event rate, and incidence of twin births. Intervention The premature infants will be randomised into one of two groups (experimental or control). Common is that both groups will have a cerebral oximeter monitoring device placed within three hours after birth. In the experimental group, the cerebral oxygenation reading is visible, and the infant will be treated accordingly using a defined treatment guideline. In the control group, the cerebral oxygenation reading is NOT visible, and the infant will be treated as usual. Trial duration Monitoring by cerebral oximeter will be started as soon as possible and within 3 hours after birth and the intervention will last for 72 hours. Thereafter, each neonate will be followed up at term date (approximately three months after birth) and at 24 months after term date. Outcome measures The primary outcome is the burden of hypo- and hyperoxia in %hours during the first 72 hours after birth. The secondary outcomes are brain activity on an amplitude-integrated electroencephalogram (aEEG), blood biomarkers (brain fatty acid binding protein (BFABP), neuroketal, and S100β), serious adverse reactions (SARs), severe brain injury, and all cause mortality at term date (approximately three months after birth). The exploratory outcomes are burden of hypoxia, burden of hyperoxia, neonatal morbidities, brain injury score on magnetic resonance imaging (MRI), number of therapies implemented during the intervention, physiological variables (mean blood pressure (BP), pulse oximeter oxygen saturation (SpO2), and partial pressure of carbon dioxide (pCO2)), and psychomotor impairment according to neurodevelopmental scales at 24 months after term date.
The investigators will obtain thromboelastography (TEG) on pediatric patients admitted to the Rady Children's Hospital ICU after traumatic brain injury on admission to our ICU and after 24 hours of care. The investigators hypothesize that TEG will identify abnormalities of coagulation that are not identified by traditional coagulation studies, i.e. prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR).
Peripheral nerve stimulation for the treatment of sequelae due to traumatic brain injury. This study will specifically examine patients with mild traumatic brain injury (TBI) who have persistent cognitive impairments lasting one year or longer. Neuropsychological testing will occur to confirm the diagnosis.
The goal of this phase of the project is to identify the elements of the Theory of Planned Behavior (TPB) that should be targeted to provide the most influence on older adults' behavior (or other stakeholders) to purchase and wear protective headwear. The investigators also intend to determine the format of communication (social marketing/academic detailing) that is most influential for different key stakeholder groups. The TPB has been useful in understanding behavior change related to exercise and adaptive equipment use (such as grab bars, canes, hip protectors); in understanding how a person's attitudes, subjective/social norms and perceived behavioral control inform the development of intention that leads to behavior change.
The purpose of this study is to determine if bone marrow harvest, BMMNC separation, and re-infusion in adults with acute severe TBI is safe and will improve functional outcome. 12/09/2015 Update: The study is closed to new enrollment and all follow-up visits have been completed. Data analysis is underway.
The purposes of this study were to evaluate the influence of an interdisciplinary rehabilitation program in the improvement of the health-related quality of life among adult neurological patients and to identify the sociodemographic and clinical associated characteristics. Subjects with spinal cord injury, acquired brain injury and poliomyelitis survivors participated in the study. All participants underwent a rehabilitation program (RP) from January 2008 through July 2010, which consists of 40-minutes of many therapies for 1-2 days a week. The WHOQOL-BREF was applied at the initial and discharge assessments.
Background: Although glucose is essential to cerebral function, abundant experimental and clinical evidence demonstrates that endogenously released lactate, rather than glucose, is the preferential energy substrate for the brain in conditions of stress and acute injury. In patients with severe Traumatic Brain Injury (TBI) and aneurysmal subarachnoid hemorrhage (SAH) monitored with cerebral microdialysis and brain tissue oxygen (PbtO2), our preliminary data show that increased brain extracellular lactate is frequently observed. Our findings indicate that elevated brain lactate more often occurs in the absence of brain hypoxia/ischemia and is mainly the consequence of increased cerebral glycolysis, i.e. it occurs in association with high extracellular pyruvate. These data suggest that the primary source of elevated lactate is activated glycolysis and strongly support the concept that endogenously released lactate can be utilized by the injured human brain as energy substrate. They prompt further investigation to examine whether exogenous lactate supplementation can be a valuable neuroprotective strategy after TBI or SAH. Indeed, in animal models of brain injury, administration of exogenous lactate improves neuronal and cognitive recovery. Hypothesis: The investigators test the hypothesis that lactate therapy, administered during the acute phase of TBI or SAH, might exercise neuroprotective actions by restoring brain energetics and improving brain tissue PO2 and cerebral blood flow (CBF). Aim of the study: The aim of this single-center study is to examine the effect of sodium lactate infusion on cerebral extracellular metabolites, brain tissue PO2 and cerebral blood flow, measured with CT perfusion and transcranial doppler (TCD). Design: Prospective phase II interventional study examining the effect of a continuous 3-6 hours infusion of sodium lactate (20-40 µmol/kg/min), administered within 48 hours from TBI or SAH, on cerebral extracellular glucose, pyruvate, glutamate, glycerol, PbtO2 and CBF.
The current conflicts in Afghanistan and Iraq have resulted in unprecedented rates of exposure to high-intensity blasts and resulting brain injury. This research team has established that recently blast-exposed Soldiers show differences from controls on tests of central auditory function. This project will 1) develop a more accurate estimate of the prevalence of central auditory dysfunction among Veterans exposed to blasts over the past ten years, 2) identify the functional outcomes associated with abnormal performance on tests of central processing, and 3) improve understanding of the ways in which blast-exposure resembles and differs from both the normal aging process and non-blast-related TBI in terms of performance on tests of central auditory processing.
The global aim of this proposal is to test and refine Common Data Elements (CDEs), neuroimaging standards, and best practices for genetics and proteomics in Traumatic Brain Injury (TBI) studies. Testing and validating of TBI-CDEs will be performed in a multi-center prospective observational study with 3 TBI Centers (San Francisco General Hospital (SFGH), University of Pittsburgh Medical Center (UPMC), University Medical Center Brackenridge (UMCB)) and a TBI Rehabilitation Center (Mount Sinai Rehabilitation Center (MSMC)). The investigators will create and expand existing data repositories for patient demographics, neuroimaging, plasma biomarkers, genetics, and multivariate outcomes thereby providing researchers and clinicians with the infrastructure to establish multidisciplinary, multicenter research networks and improve clinical research in the TBI field.
The objectives of the study are to document device performance with respect to the primary and secondary endpoints.